Rheumatoid arthritis and periodontitis Musculoskeletal Diseases Rheumatoid arthritis, unspecified and chronic periodontitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older 2. Rheumatoid arthritis diagnosed since at least one year 3. Disease Activity Score (DAS 28) score between 3.2 and 5.1 4. No change to medication, dosage or formulation in RA treatment during the 3 months before the inclusion visit 5. At least six natural teeth with root 6. Subject with periodontitis, defined by the presence of one site with periodontal probing depth = 4 mm and clinical attachment level = 3 mm on at least 4 teeth 7. Subject able to understand and willing to provide written informed consent in French 8. Subject affiliated to the security system
Exclusion criteria
Exclusion criteria: 1. Acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions 2. Planned hospitalization within 4 months after the screening visit 3. One or more known infectious diseases [Human immunodeficiency virus(HIV), hepatitis, infectious mononucleosis] 4. Known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease 5. Unbalanced diabetes 6. Known risk of endocarditis 7. Have a permanent pacemaker 8. Antithrombotic treatment 9. Severe difficulties in understanding written and spoken French 10. Pregnant, lactating, or plans to become pregnant during the study 11. Chronic disorder that requires chronic or intermittent use of antibiotics 12. Hypersensitivity to chlorhexidine gluconate 13. Participation in another study with an investigational compound 14. Contraindications to both amoxicillin and clindamycin 15. Contraindications to dental local anesthetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between 3-month and baseline DAS 28 scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between 3-month and baseline values of the following: 1. American College of Rheumatology (ACR) scores 2. Health Assessment Questionnaire (HAQ) scores 3. General Oral Health Assessment Index (GOHAI) scores 4. Periodontal Inflamed Surface Area (PISA) | — |
Countries
France